FunPep Company Limited
4881・Growth Market・Pharmaceuticals
Business
FunPep Co., Ltd. is a drug discovery biotech venture established in October 2013 with the purpose of developing functional peptides—research achievements of the Graduate School of Medicine at Osaka University—as pharmaceuticals, cosmetics, and other products. Its core technology is the proprietary antibody-inducing peptide drug discovery platform, STEP UP (Antibody-Inducing Peptide Drug Discovery Platform), through which it develops peptide therapeutic vaccines that induce antibody production within patients' bodies. Its main pipeline includes FPP004X (Target: IgE, Indication: Pollen Allergy/Seasonal Allergic Rhinitis) targeting pollen allergy (currently in Phase I clinical trials), SR-0379 (Skin Ulcer Treatment) targeting skin ulcers (undergoing additional Phase III clinical trials), and FPP003 (Target: IL-17A, Indication: Psoriasis/Ankylosing Spondylitis) targeting psoriasis and ankylosing spondylitis (clinical trials completed, currently seeking a partner). The company has built a collaborative framework with major pharmaceutical companies such as Shionogi & Co., Ltd. and Sumitomo Pharma Co., Ltd., serving as an incubator function that bridges university-originated seeds to pharmaceutical companies. The company is listed on the Growth Market of the Tokyo Stock Exchange.
Business Model
The Group adopts a lean research and development structure that keeps fixed costs down by outsourcing manufacturing and testing operations while advancing R&D in-house. Revenue consists of upfront payments, development milestones, R&D collaboration fees, royalties, and sales milestones based on partnership agreements with pharmaceutical companies. At present, the company has no marketed products, and business revenue is at a near-zero stage, with R&D expenses being funded through capital raised from capital markets via capital increases. The plan is for future post-launch royalty income to become the main source of substantial profit growth.
Company Strengths
The company possesses STEP UP, a drug discovery platform that combines AJP001 as a carrier with epitope selection know-how. In addition to IL-17A (FPP003), IgE (FPP004X), and IL-23 (FPP005), it is capable of expansion to diverse target proteins including migraine, Alzheimer's disease, hypertension, dyslipidemia, heart failure, and psychiatric/neurological disorders, serving as the foundation for pipeline expansion.
For SR-0379 (Skin Ulcer Treatment), a license agreement was concluded in October 2015, establishing a co-development structure in which Shionogi & Co., Ltd. is responsible for investigational drug manufacturing (CMC) and sales. For FPP004X (Target: IgE, Indication: Pollen Allergy/Seasonal Allergic Rhinitis), an option agreement was concluded in March 2024, granting an option for exclusive worldwide research, development, and commercialization rights across all indications. The company has secured the right to receive upfront payments, milestones, and royalties.
In the Phase I/IIa clinical trial of FPP003 (Target: IL-17A, Indication: Psoriasis/Ankylosing Spondylitis) conducted in Australia, sustained increases in anti-IL-17A antibody titers were confirmed in 78% (7 out of 9 subjects) of the high-dose cohort. No clinically significant adverse events were observed in terms of safety, demonstrating clinical-level proof of concept (PoC) for the antibody-inducing peptide.
ENVALITH's Perspective
Performance Trend
Business revenue for Q1 FY2026 (ending December 2026) (January to March 2026) was ¥0 million (versus ¥0 million in the same period of the prior year), remaining at zero. Operating loss was ¥294 million, a significant reduction from ¥603 million in the same period of the prior year. The main factor was R&D expenses falling to ¥195 million, down ¥306 million year-on-year, due to a decrease in development costs for FPP004X (Target: IgE, Indication: Pollen Allergy/Seasonal Allergic Rhinitis). Looking at annual results over the past five fiscal years, revenue has remained near zero, and in FY2025 (ending December 2025), the operating loss expanded significantly to ¥1,649 million and net loss to ¥1,912 million; however, an improvement in the cost structure was confirmed in Q1 FY2026. Total assets stood at ¥2,053 million, and cash and deposits at ¥1,867 million (up ¥98 million from the end of the previous fiscal year), maintaining liquidity on hand. There is no note regarding going concern assumptions.
Growth Strategy
Securing license revenue through clinical progress of FPP004X (Target: IgE, Indication: Pollen Allergy/Seasonal Allergic Rhinitis) and SR-0379 (Skin Ulcer Treatment), and multi-indication expansion of the STEP UP (Antibody-Inducing Peptide Drug Discovery Platform) platform
The observation period for all subjects concluded in April 2026. Data collection and analysis are proceeding, with preliminary results scheduled for disclosure in Q3 FY2026 (July-September). If the safety and immunogenicity evaluation results are favorable, license revenue is expected to arise from Shionogi & Co.'s exercise of its option right (exclusive worldwide research, development, and commercialization rights for all indications).
Study 02, which began in December 2024, completed enrollment of half the target number of subjects in December 2025, and progress is proceeding smoothly. This trial verifies the reproducibility of the efficacy confirmed in the post-hoc subgroup analysis of Study 01; if the results are favorable, the program will advance to the next step toward a regulatory approval application and market launch through joint development with Shionogi & Co.
Proof of concept for antibody production has been achieved in a Phase I/IIa trial (Australia) targeting psoriasis vulgaris. An investigator-initiated trial (Phase IIa) targeting ankylosing spondylitis has also been conducted. Based on these early clinical trial results, alliance activities to secure a new development partner are ongoing.
Through joint research with Osaka University, Kumamoto University, and the University of Tokyo, exploratory research on antibody-inducing peptides targeting migraine, Alzheimer's disease, hypertension, antithrombosis, dyslipidemia, and heart failure is underway. Joint research on a new vaccine adjuvant with Shionogi & Co. (begun in October 2024) is also being advanced in parallel to strengthen formulation technology.
Research on specialty peptide drug discovery using cyclic peptides containing non-natural amino acids is underway. By entering this field, which is expected to be a next-generation modality, the company aims to build a new technological foundation that complements its existing antibody-inducing peptide platform.
Last updated: July 17, 2026